# K973271: Skar-Kare

- Pathway: 510(k) (Traditional)
- Applicant: Target Health, Inc.
- Decided: Nov 19, 1997 after 78 days
- Product code: MDA (Elastomer, Silicone, For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953420 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953420: Silk*Skin Scar Treatment, Silk*Skin Care Co. (1995) Summary page 2.

## Indications for use
SKAR-KARE ™ is indicated for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.

Source page: https://510kreport.com/device/K973271
Methodology: https://510kreport.com/methodology